SENSAR IOL AR40e (REF AR40E00155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474502017), received between Mar 30, 2017 and May 7, 2026 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED AN ISSUE INVOLVING THE AR40E INTRAOCULAR LENS, SERIAL NUMBER (B)(6), WHICH WAS USED IN A LEFT EYE PROCEDURE. DURING INSERTION, THE PHYSICIAN EXPERIENCED DIFFICULTY, RESULTING IN AN UNPLANNED VITRECTOMY BEFORE COMPLETING THE PROCEDURE WITH A BACKUP LENS OF THE SAME MODEL AND SERIAL NUMBER. THE ORIGINAL LENS WAS NOT FULLY INSERTED; INCISION ENLARGEMENT WAS NOT REQUIRED, BUT SUTURES WERE APPLIED AS A PRECAUTIONARY MEASURE, WHICH WAS NOT PART OF THE INITIAL PLAN. THE PATIENT¿S PROGNOSIS FOLLOWING THE PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 25113337 ↗
• MalfunctionApr 30, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE AR40E MODEL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND SUBSEQUENTLY EXPLANTED DURING THE SAME PROCEDURE FOR REASONS THAT WERE NOT DOCUMENTED. A REPLACEMENT AR40E 15.5 IOL WAS THEN IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED DURING THE PROCEDURE. THE PATIENT¿S POST-OPERATIVE PROGNOSIS WAS REPORTED AS GOOD. THE EXPLANTED IOL IS NOT AVAILABLE FOR INVESTIGATION, AS IT WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049362 ↗
• InjuryJul 17, 2025Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT A NON-PRELOADED LENS HAD A TORN BOTTOM HAPTIC, AND THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED. THE LENS WAS PLACED AND THEN REMOVED DURING THE SAME PROCEDURE, INVOLVING THE SAME DIOPTER AND MODEL OF IOL. ADDITIONAL INFORMATION REVEALED THAT THE SURGEON LOADED THE LENS BUT DID NOT REALIZE THAT THE BOTTOM HAPTIC WAS TORN UNTIL AFTER THE LENS HAD BEEN INSERTED INTO THE EYE. CONSEQUENTLY, THE SURGEON HAD TO CUT THE LENS INTO TWO PIECES TO REMOVE IT. THE PATIENT REQUIRED SUTURES, AND THE INCISION WAS ENLARGED DURING THE PROCEDURE. THE PATIENT IS NOW FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22538724 ↗
• InjuryMay 8, 2025Material Fragmentation; Material Fragmentation

  THE AR40E MODEL INTRAOCULAR LENS (IOL) WAS INSERTED IN THE PATIENT'S OPERATIVE EYE AND THEN REMOVED DUE TO THE TRAILING HAPTIC BEING AMPUTATED. IT IS UNKNOWN IF ANOTHER IOL WAS INSERTED. AN UNPLANNED ANTERIOR VITRECTOMY WAS PERFORMED. THERE WAS NO USER ERROR AND THERE WAS NOTHING ABNORMAL WITH INSERTING THE IOL INTO THE CARTRIDGE, MODEL UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 21983052 ↗
• MalfunctionJan 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED IN THE PATIENT'S RIGHT EYE, BUT WAS SUBSEQUENTLY DEEMED UNSUITABLE AND WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE, WITH A NEW IOL OF THE SAME MODEL AND POWER BEING IMPLANTED INSTEAD. THE PROCEDURE EXPERIENCED A 10-MINUTE DELAY. THE PATIENT'S PRE AND POST-OPERATIVE VISUAL ACUITIES, THE NEED FOR INCISION ENLARGEMENT, VITRECTOMY, SUTURES, AND WHETHER THE PATIENT SOUGHT ADDITIONAL MEDICAL ATTENTION OR WAS PRESCRIBED MEDICATION REMAIN UNKNOWN. HOWEVER, IT IS NOTED THAT THE PATIENT HAS FULLY RECOVERED, AND DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. THE DIRECTIONS FOR USE WERE FOLLOWED. THROUGH FOLLOW UP IT WAS LEARNED THAT IT IS UNKNOWN WHY THE LENS WAS "NOT GOING TO WORK". THERE WAS NO CALCULATION ISSUE, AS THE SAME LENS AND POWER WERE INSERTED. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED AND THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT OUTCOME IS UNKNOWN. THERE WAS NO ISSUE WITH THE IOL NOTED. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137928 ↗
• MalfunctionOct 2, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT NON-PRELOADED MONOFOCAL LENS HAD DEFECTIVE HAPTICS. ADDITIONAL INFORMATION SUGGESTS THAT THE LEADING HAPTIC HAD A KINK SUCH THAT IT WASN'T ROUNDED APPROPRIATELY. THIS WAS WITHDRAWN BEFORE FULL DELIVERY. THE SECOND LENS HAD THE TRAILING HAPTIC POP OFF ONCE IMPLANTED IN THE EYE DUE TO USE ERROR. TO ADDRESS THE ISSUE, A THIRD AR40E LENS WAS CENTERED AND PLACED IN THE SULCUS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352461 ↗
• MalfunctionSep 27, 2024Break; Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20318167 ↗
• MalfunctionJul 24, 2024Break; Break

  IT WAS REPORTED THAT THE NON PRELOADED MONOFOCAL LENS HAD A MANUFACTURER DEFECT. REPORTEDLY HAPTIC BROKE WHILE BEING POSITIONED. THE LENS WAS FULLY INSERTED, REMOVED AND REPLACED DURING THE SAME PROCEDURE. NO INJURY OR MEDICAL INTERVENTION IS REQUIRED. DIFFERENT LENS FROM DIFFERENT MANUFACTURERS WAS USED. THE PATIENT'S STATUS IS UNKNOWN. THE PRODUCT IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822747 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR NOTICED THAT FOUR (4) PATIENTS HAD INCREASED INFLAMMATION POST-OP. THE DOCTOR STATED HE WAS THINKING IT WAS DUE TO TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE DOCTOR DID HIS OWN DUE DILIGENCE TO SEE IF THERE WAS A TREND. HE REVIEWED THE SURGERIES TO INCLUDE ANY PROCEDURAL CHANGES, PRODUCT CHANGES OR OPERATING ROOM CHANGES. NOTHING WAS FOUND TO BE DIFFERENT. LAB CULTURES WERE NOT PERFORMED, NOR ANY TESTING FOR TASS. THE PATIENTS HAD INCREASED INFLAMMATION THAT DID NOT SUBSIDE, AND A PATIENT ALSO HAD CORNEAL EDEMA. THE DOCTOR TREATED THE PATIENTS WITH INCREASED POST-OP MEDICATION WITH A CHANGE IN DOSAGE FROM THE USUAL FREQUENTLY TO EVERY HOUR INSTEAD. PATIENTS WERE PRESCRIBED OFLOXACIN (ANTIBIOTIC), PREDNISOLONE, AND KETOROLAC (COMBINATION ANTIBIOTIC, ANTI-INFLAMMATORY AND STEROID). THE DOCTOR NOTICED THE PATIENT¿S SYMPTOMS WERE SUBSIDING. NO PLAN TO REMOVE ANY OF THE LENSES AND THUS FAR, ALL PATIENTS WERE OK. THIS MDR REPORT PERTAINS TO THE FIRST OF FOUR EVENTS. A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER LENSES.

  Patient problems: Corneal Edema; Endophthalmitis; Inflammation

  MAUDE report 8724955 ↗
• InjuryApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZLB00 +16.5 DIOPTER) WAS EXPLANTED IN SECONDARY SURGICAL PROCEDURE FROM PATIENT¿S LEFT EYE BECAUSE OF PATIENT EXPERIENCING DIZZINESS DUE TO MIX MATCH INTRAOCULAR LENS. A SENSAR MONOFOCAL INTRAOCULAR LENS (MODEL AR40E +15.5 DIOPTER) WAS USED AS THE REPLACEMENT. LATER THE SENSAR MONOFOCAL INTRAOCULAR LENS (MODEL AR40E +15.5 DIOPTER) WAS ALSO EXPLANTED IN SECONDARY SURGICAL PROCEDURE BECAUSE OF SAME REASON, PATIENT EXPERIENCING DIZZINESS. A MODEL ZXR00 +16.5 DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT'S PRE-OP VISION WAS 0.5. POST-OP VISION WITH THE TECNIS, ZLB00 LENS WAS 0.8. NO FURTHER INFORMATION PROVIDED. THIS REPORT WILL CAPTURE INFORMATION FOR SECOND EXPLANT MODEL (AR40E +15.5 DIOPTER).A SEPARATE REPORT IS BEING SENT FOR FIRST EXPLANT MODEL ZLB00 +16.5 DIOPTER).

  Patient problems: Dizziness; No Code Available

  MAUDE report 8507511 ↗
• MalfunctionNov 1, 2018Break; Break

  IT WAS REPORTED THAT WHEN BEING INSERTED INTO THE EYE AN AR40E INTRAOCULAR LENS (IOL) HAD BROKEN HAPTIC. IT WAS STATED THAT THE TRAILING HAPTIC WAS PINCHED AND NEARLY BROKEN WHEN IMPLANTED. IOL WAS REMOVED FROM THE PATIENT AND ANOTHER LENS WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8031561 ↗
• MalfunctionMar 30, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT A SCRATCH WAS FOUND ON AN INTRAOCULAR LENS (IOL) BEFORE SURGERY, PRIOR TO FOLDING THE LENS. NO PATIENT INVOLVEMENT OR INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6447457 ↗